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510(k) K831904

RABBIT ANTISERUM TO HUMAN KAPPA LIGHT by Dako Corp. — Product Code DEO

K831904 is an FDA 510(k) premarket notification submitted by Dako Corp. for the device "RABBIT ANTISERUM TO HUMAN KAPPA LIGHT". The FDA issued a decision of Substantially Equivalent on July 19, 1983. The device falls under product code DEO (Kappa, Fitc, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5550. Dako Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 1983
Date Received
June 14, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kappa, Fitc, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5550
Review Panel
IM
Submission Type

Other clearances by Dako Corp.

  • K041627 — CYSTATIN C IMMUNOPARTICLES, CONTROL SET, CALIBRATOR (September 3, 2004)
  • K032692 — DAKOCYTOMATION BETA-2-MICROGLOBULIN KIT, CODE NO. OA 368 (January 22, 2004)
  • K020023 — DAKO MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, ANTIBODY (February 28, 2002)
  • K993957 — DAKO MONOCLONAL MOUSE ANTI-HUMAN ESTROGEN RECEPTOR (March 3, 2000)
  • K991402 — DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE-CY5, CLONE UCHT1 & DAKO MOUSE ANTI-HUMAN T (June 21, 1999)
  • K991454 — MOUSE IGG1 NEGATIVE CONTROLS (June 21, 1999)
  • K980635 — DAKO MOUSE ANTI-HUMAN B-CELL, CD19/RPE-CY5, CLONE HD37 (July 22, 1998)
  • K971905 — DAKO MOUSE ANTI HUMAN CYTOKERATIN, HIGH MOLECULAR WEIGHT, CLONE 34BE12, MONOCLON (December 12, 1997)
  • K965022 — MONOCLONAL MOUSE ANTI-HUMAN CD30, KI-1 ANTIGEN, BER-H2 ANTIBODY FOR IMMUNOENZYMA (November 6, 1997)
  • K964974 — MOUSE ANTI-HUMAN CD45, LEUCOCYTE COMMON ANTIGEN (LCA)/FITC AND CD14, MONOCYTE/RP (June 24, 1997)

Other clearances for product code DEO

  • K832260 — GOAT ANTI-HUMAN KAPPA AFFINITY (October 31, 1983)

FDA data resources